Quick Facts at a Glance
- Recall Date
- April 14, 2026
- Hazard Level
- HIGH
- Brands
- MONSELS SOLUTION, Premier Dental Products Company
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- MONSELS SOLUTION, Premier Dental Products Company
- Model numbers
- Lot #: 640911253, Exp Date. 09/14/2027.
- UPC codes
- 48783-112, 48783-112-08
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 14, 2026
Reported by FDA DRUG
April 29, 2026
RecallRadar source check
May 6, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Premier Dental Products Co or your healthcare provider for guidance. Notification method: E-Mail
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Full Description
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.. Generic: FERRIC SUBSULFATE; Brand: MONSELS SOLUTION. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.. Classification: Class III. Quantity: 573 cartons. Distribution: Nationwide within the United States
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Safety Guide
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